Dexilant

Medicinal product

(Invented) name

Dexilant

Active substance (s)

Dekslansoprazolas

Strength

60 mg

Pharmaceutical form

modifikuoto atpalaidavimo kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A02BC06, Dexlansoprazole

Marketing authorisation holder

Takeda Pharma A/S, Danija

Date of authorisation

2013-10-31

Date of renewal

2023-09-19

Documents

3415 Dexilant RPP 2024 09 02.docx

3415 Pakuotės lapelis 2024 09 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/1000/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dekslansoprazolas	60 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
51795	65693	1065693	lizdinė plokštelė	N14		Receptinis	LT/1/13/3415/003	Tiekiama	-	-	No	-	-	Download
57733	71853	1071853	lizdinė plokštelė	N28		Receptinis	LT/1/13/3415/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-19	Perregistruotas
2013-10-31	Registruotas